Gut and saliva microbiota changes after taking Bacillus coagulans probiotics
Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria
We will test whether taking a Bacillus coagulans probiotic for 14 days changes the bacteria in stool and saliva of healthy adults aged 18–65.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Lund University Academic / other |
| Locations | 1 site (Lund) |
| Trial ID | NCT07046897 on ClinicalTrials.gov |
What this trial studies
Healthy adults aged 18–65 will take a freeze-dried Bacillus coagulans probiotic daily for 14 days and collect saliva and fecal samples before and after the intervention. Samples will be frozen immediately and analyzed at Lund University using Illumina MiSeq sequencing and the QIIME2 pipeline to measure species composition, diversity, and relative abundance. People with gastrointestinal disease, autoimmune conditions, recent antibiotic use, or who consume other probiotic products or fermented foods are excluded. The study asks whether the probiotic produces changes in microbiota composition that would be considered beneficial.
Who should consider this trial
Good fit: Healthy adults aged 18–65 who are not on antibiotics, do not have gastrointestinal or autoimmune diseases or immune-suppressing conditions, and agree to avoid other probiotic or fermented foods during the study.
Not a fit: People with diagnosed GI or autoimmune diseases, significant immune deficiency, recent antibiotic use, or those already using other probiotic products are unlikely to receive benefit from this healthy-volunteer study.
Why it matters
Potential benefit: If successful, the results could support using Bacillus coagulans to beneficially shift saliva and gut microbiota in healthy people and guide future research for clinical applications.
How similar studies have performed: Previous probiotic research has produced mixed results—some trials report microbiota changes while others do not—and evidence specific to Bacillus coagulans in healthy adults remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • You must be 18-65 years of age. Exclusion Criteria: * Participants must not be diagnosed with gastrointestinal diseases, autoimmune diseases or have diseases or medications that cause immune deficiency such as MS, type 1 diabetes, cancer or HIV. * Participants must not have taken antibiotics in the month before or during the study. * Participants must not consume other probiotic products or fermented foods during the study.
Where this trial is running
Lund
- Department of Process and Life Science Engineering, Lund University — Lund, Sweden (Recruiting)
Study contacts
- Principal investigator: Åsa Håkansson, Associate Professor — Lund University, LTH
- Study coordinator: Åsa Håkansson, Associate Professor
- Email: asa.hakansson@ple.lth.se
- Phone: +46 46 2228326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.